17 December 2016

The Generic and Biosimilar Medicines Association (GBMA) welcomes a recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC) to list Renflexis® on the Pharmaceutical Benefits Scheme (PBS) and looks forward to it becoming widely available to patients next year.

Renflexis is the second biosimilar infliximab to be approved in Australia, providing an alternative, affordable treatment option for patients living with a range of diseases including rheumatoid arthritis, psoriasis, and Crohn’s disease.

With Pfizer’s biosimilar Inflectra® (infliximab) gaining only three percent market share in its first year, the PBS savings from biosimilar infliximab are yet to be realised. It is through biosimilar market entry, PBS listing and competition that Australia can unlock the full value offered by biosimilars.

“The success of biosimilars in Australia will rely on physician confidence, patient awareness and policies to support uptake,” said GBMA CEO, Belinda Wood.

“With the recommendation to list the second biosimilar infliximab, ignoring the evidence in support of biosimilars is no longer an option. 10 years of biosimilar experience in Europe with over 400 million patient days has demonstrated the safety and efficacy of these medicines,”

“Additionally, clinical trials such as NOR-SWITCH and EGALITY have now demonstrated patients can be safely switched from an original brand biologic to a biosimilar with no loss of clinical effect,”

“GBMA encourages physicians to look at the evidence supporting biosimilars and take a leadership role in supporting PBS affordability through their increased use,”

“GBMA welcomes the roll out of the initial products of the biosimilar awareness initiative which will provide essential information on biosimilars for healthcare professionals, pharmacists and consumers, and looks forward to further elements of the initiative in 2017.” she said.

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BACKGROUND: 

Details regarding NOR-SWITCH and EGAILTY can be obtained at: httpss://clinicaltrials.gov/ct2/home

A biosimilar is a biological medicine that is determined to be comparable in quality, safety, and efficacy to the reference biological medicine following a full evaluation by the TGA. Biosimilars offer therapeutically equivalent and more cost-effective alternatives to existing, high-cost biological medicines.

Previously the Generic Medicines Industry Association (GMiA), the Generic and Biosimilar Medicines Association announced a name change in July 2015 to signal the significant role the association will continue to play in the access to affordable medicines.

The Generic and Biosimilar Medicines Association is the national association representing companies that manufacture, supply and export generic and biosimilar medicines. The generic and biosimilar medicines sector is a high value-add sector delivering significant health and economic benefits to the Australian public.

The availability of generic and biosimilar medicines in this country helps to deliver:

• timely access to affordable medicines; substantial savings to the Pharmaceutical Benefit Scheme; and
• thousands of highly skilled jobs; and domestic manufacturing and exports of over $300 million

Generic and biosimilar medicines deliver the same health benefit to all Australians as the original brand and they must meet the same strict Australian standards, including the same manufacturing requirements, as branded medicines.

ENQUIRIES:

Belinda Wood                                    M 0431 792 711

Chief Executive Officer                      E  belinda.wood@gbma.com.au

28 November 2016

Visiting UK clinician may have the solution to healthcare affordability, enabling wider patient access to the latest medicines while delivering savings to the Pharmaceutical Benefits Scheme (PBS) budget.

Dr Paul Cornes, an oncologist from Bristol is visiting Australia this week to encourage doctors and policy makers to embrace the patient and health system opportunities with biosimilars and to share international best practice as a key to advancing future care.

This is an excellent opportunity for Australia to hear from an international expert who uses biosimilars in his clinical practice and influences healthcare policy throughout Europe.

Speaking from personal experience, Dr Cornes will meet with a range of policy makers, clinicians, and consumer groups, providing examples of how government policy can enhance individual patient care. He has seen how greater uptake of biosimilars deliver affordable healthcare, the best patient outcomes and can fund future innovations in medicine.

As an example, he will outline how biosimilar filgrastim (used to treat neutropenia, or low white blood cell count, that threatens infections in people undergoing cancer chemotherapy) enables him to treat patients with lower risk or earlier stage disease, resulting in five times more patients being treated over two years, all while delivering millions in NHS savings that can be reinvested in new treatments.

Dr Cornes will encourage Australian doctors to take a leadership role in using biosimilars and not to let a perceived risk of immunogenicity prevent them from embracing the opportunity with biosimilars, outlining that in over ten years of clinical experience with biosimilars in Europe, enhanced immunogenicity has not been observed.

-ENDS-

BACKGROUND:

A biosimilar is a biological medicine that is determined to be comparable in quality, safety, and efficacy to the reference biological medicine following a full evaluation by the TGA. Biosimilars offer therapeutically equivalent and more cost-effective alternatives to existing, high-cost biological medicines.

Previously the Generic Medicines Industry Association (GMiA), the Generic and Biosimilar Medicines Association announced a name change in July 2015 to signal the significant role the association will continue to play in the access to affordable medicines.

The Generic and Biosimilar Medicines Association is the national association representing companies that manufacture, supply and export generic and biosimilar medicines. The generic and biosimilar medicines sector is a high value-add sector delivering significant health and economic benefits to the Australian public.

The availability of generic and biosimilar medicines in this country helps to deliver:

• timely access to affordable medicines; substantial savings to the Pharmaceutical Benefit Scheme; and
• thousands of highly skilled jobs; and domestic manufacturing and exports of over  $300

million

Generic and biosimilar medicines deliver the same health benefit to all Australians as the original brand and they must meet the same strict Australian standards, including the same manufacturing requirements, as branded medicines.

15 September 2016

Australia can streamline the regulation of therapeutic goods by removing duplicative and inefficient processes without undermining the safety and quality of medicines, according to an independent review of medicines regulation.

The 2015 report of the Expert Review of Medicines and Medical Device Regulation makes 32 recommendations, many of which would improve regulatory efficiency and deliver more timely patient access to generic and biosimilar medicines.

An announcement today by Health Minister Sussan Ley to implement a number of these recommendations is welcomed by the Generic and Biosimilar Medicines Association (GBMA).

“Initiatives to drive regulatory efficiency and reduce the red-tape burden for generic and biosimilar medicine suppliers, without compromising on quality or safety, benefit patients, taxpayers and industry,” GBMA CEO, Belinda Wood said.

“GBMA is highly supportive of improvements in the regulation of medicines that will result in faster approval times for new generic and biosimilar medicines, streamlined administrative requirements and reduced costs for industry,”

“It currently takes just over a year for the Therapeutic Goods Administration (TGA) to evaluate and approve a generic medicine.  Reducing this time will bring new affordable medicines to patients sooner, increase treatment options for doctors and deliver savings for the PBS,”

“GBMA also welcomes the recommendation to streamline post-market requirements for medicines as it brings TGA processes in step with respected international regulatory bodies,”

“Enabling changes to products already in the Australian Register of Therapeutic Goods to be made faster, and with less red-tape, will ensure ongoing quality, patient safety and continuity of supply of affordable medicines.” she said.

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26 July 2016

Brenzys^® is the first biosimilar etanercept to be approved in Australia, providing an alternative, affordable treatment option for patients living with a range of diseases including rheumatoid arthritis, psoriasis, and ankylosing spondylitis.

The Generic and Biosimilar Medicines Association (GBMA) welcomes the approval of Brenzys by the Therapeutic Goods Administration (TGA), and looks forward to it becoming widely available to patients through the Pharmaceutical Benefits Scheme (PBS).

“Biosimilars are increasingly being used around the world to increase patient access to life changing medicines and reduce treatment costs. The availability, and PBS listing, of biosimilars in Australia will deliver significant PBS savings and enable more patients to be treated within the same budget,” said GBMA CEO, Belinda Wood.

“With Pfizer’s Enbrel^® (etanercept) currently costing the PBS $180 million per year, the approval of Brenzys introduces important competition into the Australian market. It is through biosimilar market entry, PBS listing and competition that Australia is able to unlock the full value offered by biosimilars,”

“However, savings can only be realised if more affordable biosimilars are listed on the PBS, prescribed by doctors and dispensed by pharmacists,”

“GBMA encourages the government to fast-track the roll out of its $20million biosimilar awareness initiative to provide essential information on biosimilars for healthcare professionals, pharmacists and consumers,” she said.

ENDS

4 May 2016

The 2016 Budget confirms the significant ongoing Pharmaceutical Benefits Scheme (PBS) savings provided by generic medicines, and signals the government’s intent to streamline medicine regulation processes. The absence of further PBS reform honours the commitment in the 2015 Strategic Agreement between the Generic and Biosimilars Medicines Association (GBMA) and the Australian Government.

“Since 2007, the pharmaceutical industry has gone through a period of unprecedented change.  In this time, the generic medicines industry has consistently delivered significant PBS savings – first through competition and then through price disclosure,” said GBMA Chair Allan Tillack.

“We are pleased to have confirmation in the 2016 Budget that the Strategic Agreement between GBMA and the Australian Government has been honoured and no further savings measures have been introduced into the F2 formulary,” he said.

The Budget papers outline a commitment to implement recommendations made in the Review of Medicine and Medical Device Regulations. GBMA supports improvements in the regulation of generic and biosimilar medicines that will result in faster approval times for new generic and biosimilar medicines, streamlined administrative requirements and reduced costs for industry.

“Initiatives to drive regulatory efficiency and reduce the administrative and cost burden for generic and biosimilar medicine suppliers, without compromising on quality or safety, benefit patients, taxpayers and industry,” said Mr Tillack.

“It takes just over a year for the Therapeutic Goods Administration to evaluate and approve a generic medicine.  Reducing this time will bring new affordable medicines to patients sooner, increase treatment options for doctors and deliver savings for the PBS,” he said.

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